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1. Ananase
2. Bromelain
3. Bromelain Pos
4. Bromelain-pos
5. Bromelainpos
6. Bromelains
7. Bromelin
8. Bromelins
9. Dayto Anase
10. Debrase
11. Dontisanin
12. Extranase
13. Mucozym
14. Proteozym
15. Traumanase
1. Muxf
2. M0xf(3)
3. Bromelain, Technical Grade
4. Chebi:53469
5. 9001-00-7
6. Fuc-alpha-(1->3)-[man-alpha-(1->6)-[xyl-beta-(1->2)]-man-beta-(1->4)-glcnac-beta-(1->4)]-glcnac
7. Alpha-l-fuc-(1->3)-[alpha-d-man-(1->6)-[beta-d-xyl-(1->2)]-beta-d-man-(1->4)-beta-d-glcnac-(1->4)]-d-glcnac
8. Alpha-l-fucopyranosyl-(1->3)-[alpha-d-mannopyranosyl-(1->6)-[beta-d-xylopyranosyl-(1->2)]-beta-d-mannopyranosyl-(1->4)-2-acetamido-2-deoxy-beta-d-glucopyranosyl-(1->4)]-2-acetamido-2-deoxy-d-glucopyranose
9. Alpha-l-fucosyl-(1->3)-[alpha-d-mannosyl-(1->6)-[beta-d-xylosyl-(1->2)]-beta-d-mannosyl-(1->4)-n-acetyl-beta-d-glucosaminyl-(1->4)]-n-acetyl-d-glucosamine
10. Alpha-l-fucp-(1->3)-[alpha-d-manp-(1->6)-[beta-d-xylp-(1->2)]-beta-d-manp-(1->4)-beta-d-glcpnac-(1->4)]-d-glcpnac
11. Bromelaine
12. Epitope Id:115005
13. Q27124066
14. N_full_22100100000000_gs_1023_c1
15. Man(a1-6)[xyl(b1-2)]man(b1-4)glcnac(b1-4)[fuc(a1-3)]glcnac
16. Wurcs=2.0/6,6,5/[a2122h-1x_1-5_2*ncc/3=o][a1221m-1a_1-5][a2122h-1b_1-5_2*ncc/3=o][a1122h-1b_1-5][a212h-1b_1-5][a1122h-1a_1-5]/1-2-3-4-5-6/a3-b1_a4-c1_c4-d1_d2-e1_d6-f1
Molecular Weight | 1026.9 g/mol |
---|---|
Molecular Formula | C39H66N2O29 |
XLogP3 | -11.6 |
Hydrogen Bond Donor Count | 18 |
Hydrogen Bond Acceptor Count | 29 |
Rotatable Bond Count | 16 |
Exact Mass | 1026.37512407 g/mol |
Monoisotopic Mass | 1026.37512407 g/mol |
Topological Polar Surface Area | 483 Ų |
Heavy Atom Count | 70 |
Formal Charge | 0 |
Complexity | 1680 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 28 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Bromelain has /shown/ some success as a substitute for trypsin and pepsin in cases of pancreatic insufficiency and post-pancreatectomy.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.72 (2001)
Acute postoperative and post-traumatic conditions of swelling, especially of the nasal and paranasal sinuses.
Blumenthal M, ed; The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines p.94 (1998)
In an open case observation study involving patients with blunt injuries to the musculoskeletal system, the efficacy and tolerability of high-dose Bromelain POS, a plant-derived enzyme preparation, were investigated. The investigating physician was an orthopedic surgeon who, in addition to the usual therapeutic measures, treated 59 of his patients with the bromelaine preparation. The duration of the application was determined by the nature and severity of the lesion, and varied between one and three weeks. The test criteria were swelling, pain at rest and during movement, and tenderness. These parameters were evaluated on the day of the injury and on five subsequent dates. Treatment with bromelaine resulted in a clear reduction in all four parameters tested. Both swelling and the symptoms of pain had improved appreciably at all evaluation time points as compared with baseline. The tolerability of the preparation was very good, and patient compliance was correspondingly high.
PMID:7672747 Masson M; Fortschr Med 113 (19): 303-6 (1995)
Gastrointestinal symptoms such as nausea and vomiting, diarrhea and cramping have been reported. There are occasional reports of metrorrhagia and menorrhagia.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.72 (2001)
As with papain and other proteases, bromelain may cause contact allergenic reactions in certain individuals.
Leung, A.Y., Foster, S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics. New York, NY. John Wiley & Sons, Inc. 1996., p. 101
Bromelain supplements should be avoided by pregnant women and nursing mothers.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.70 (2001)
In one double-blind study of 73 patients with acute thrombophlebitis, bromelain, used with analgesics, reduced pain, edema, redness, tenderness, elevated skin temperature and disability.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.72 (2001)
Those on anticoagulants or antithrombotic agents should exercise caution in the use of bromelain. Bromelain may have blood thinning activity in some.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.70 (2001)
Evidence that bromelains (I) is absorbed from the gastrointestinal tract of rats after oral administration is demonstrated in a bioavailability study in which 125I is given by oral route to rats and blood levels sampled at various times thereafter. A maximum level of 270 ng/ml I was found at one hr after administration.
PMID:3207859 White RR et al; Biopharm Drug Dispos 9 (Jul-Aug): 397-403 (1988)
Bromelain, a standardized complex of proteases from the pineapple plant, is absorbed unchanged from the intestine of animals at a rate of 40% ... .
PMID:2203073 Lotz-Winter H; Planta Med 56 (3): 249-53 (1990)
It has been postulated that a minor enzymatic component present in bromelain is responsible for the release of a kinin, which stimulates the production of prostaglandin E1-like compounds; These PGE1-like compounds are then responsible for the physiological activities of bromelain.
Leung, A.Y., Foster, S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics. New York, NY. John Wiley & Sons, Inc. 1996., p. 101
Bromelain's digestant activity is based on its ability to hydrolyze proteins to oligopeptides and amino acids. Bromelain's proteolytic enzymes are cysteine proteases. Cysteine proteases cleave peptide bonds by nucleophilic attack via active-site cysteine residues.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.71 (2001)
The mechanism of the putative anti-inflammatory activity ... may be accounted for, in part, by activation of plasmin production from plasminogen and reduction of kinin via inhibition of the conversion of kininogen to kinin. Other possibilities, may include proteolytic degradation of circulating immune complexes and inhibition of signaling by extracellular regulated kinase (ERK-2) and p21 ras.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.71 (2001)
Bromelain has been shown to increase CD2-mediated T cell activation, to enhance antigen-independent binding to monocytes and to increase interferon (IFN)-gamma-dependant, tumor necrosis factor (TNF)-alpha, Interleukin (IL)-1 beta, and interleukin (IL)-6 production in peripheral blood monocytes. These effects are thought to be due to bromelains proteolytic activity at cell surfaces, whereby it either removes surface molecules or reveals ones that already exist on cell membranes, thereby altering receptor-ligand interactions.
Medical Economics Co; Physicians Desk Reference for Nutritional Supplements 1st ed p.71 (2001)
For more Mechanism of Action (Complete) data for BROMELAINS (7 total), please visit the HSDB record page.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35092
Submission : 2020-08-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27173
Submission : 2013-05-06
Status : Inactive
Type : II
Registration Number : 220MF10157
Registrant's Address : Building D, Yinkai Industrial Park, Nanyan Line, Shajing Avenue, Nanning, China
Initial Date of Registration : 2008-06-30
Latest Date of Registration : --
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 391
Submission : 1960-07-18
Status : Inactive
Type : II
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Details:
MW005, our topical enzymatic therapy for the treatment of non-melanoma skin cancers received positive initial data from the Company’s U.S. Phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC).
Lead Product(s): Bromelain
Therapeutic Area: Oncology Brand Name: MW005
Study Phase: Phase I/ Phase IIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Lead Product(s) : Bromelain
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : MW005, our topical enzymatic therapy for the treatment of non-melanoma skin cancers received positive initial data from the Company’s U.S. Phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC).
Brand Name : MW005
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 10, 2023
Details:
The Company intends to use the net proceeds from the offering primarily for the acceleration of the development of EscharEx® (bromelain), establishing a U.S. commercial presence, supporting business development activities, and for general corporate purposes.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: EscharXR
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: H.C. Wainwright & Co.
Deal Size: $27.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 07, 2023
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : H.C. Wainwright & Co.
Deal Size : $27.5 million
Deal Type : Public Offering
MediWound Announces Closing of $27.5 Million Registered Direct Offering of Ordinary Shares
Details : The Company intends to use the net proceeds from the offering primarily for the acceleration of the development of EscharEx® (bromelain), establishing a U.S. commercial presence, supporting business development activities, and for general corporate purp...
Brand Name : EscharXR
Molecule Type : Large molecule
Upfront Cash : Undisclosed
February 07, 2023
Details:
The Company intends to use the net proceeds from the offering primarily for the acceleration of the development of EscharEx. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy to use product candidate, for topical daily applications.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: EscharXR
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: H.C. Wainwright & Co.
Deal Size: $27.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 03, 2023
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : H.C. Wainwright & Co.
Deal Size : $27.5 million
Deal Type : Public Offering
Details : The Company intends to use the net proceeds from the offering primarily for the acceleration of the development of EscharEx. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy to use product candidate, for topical daily appl...
Brand Name : EscharXR
Molecule Type : Large molecule
Upfront Cash : Undisclosed
February 03, 2023
Details:
Through the acquisition, Sun Pharma strengthen its anti-inflammatory portfolio by adding Disperzyme (bromelain), Disperzyme-CD and Phlogam from Aksigen Hospital Care.
Lead Product(s): Bromelain,Trypsin,Rutin
Therapeutic Area: Neurology Brand Name: Disperzyme
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Sun Pharmaceutical Industries Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 30, 2023
Sun Pharma Acquires Disperzyme® and Phlogam® Brands to Strengthen Its Anti-Inflammatory Portfoli...
Details : Through the acquisition, Sun Pharma strengthen its anti-inflammatory portfolio by adding Disperzyme (bromelain), Disperzyme-CD and Phlogam from Aksigen Hospital Care.
Brand Name : Disperzyme
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 30, 2023
Details:
NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: NexoBrid
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MediWound Expands Global Presence as NexoBrid® Gains Approval in India
Details : NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four h...
Brand Name : NexoBrid
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 13, 2022
Details:
NexoBrid (bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: NexoBrid
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NexoBrid (bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue...
Brand Name : NexoBrid
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 03, 2022
Details:
BARDA is providing funds to develop NexoBrid & support NexoBrid’s potential approval to enhance U.S preparedness. NexoBrid, product for non-surgical eschar removal & full-thickness thermal burns, is a bromelain-based product containing a sterile mixture of proteolytic enzymes.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: NexoBrid
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Biomedical Advanced Research and Development Authority
Deal Size: $211.0 million Upfront Cash: Undisclosed
Deal Type: Funding February 10, 2022
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biomedical Advanced Research and Development Authority
Deal Size : $211.0 million
Deal Type : Funding
Details : BARDA is providing funds to develop NexoBrid & support NexoBrid’s potential approval to enhance U.S preparedness. NexoBrid, product for non-surgical eschar removal & full-thickness thermal burns, is a bromelain-based product containing a sterile mixtur...
Brand Name : NexoBrid
Molecule Type : Large molecule
Upfront Cash : Undisclosed
February 10, 2022
Details:
The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MW005 in removing non-melanoma skin cancers and pre-cancerous lesions (e.g., actinic keratosis, BCC, and squamous cell carcinoma) in up to 50 patients.
Lead Product(s): Bromelain
Therapeutic Area: Oncology Brand Name: MW005
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Lead Product(s) : Bromelain
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MW005 in removing non-melanoma skin cancers and pre-cancerous lesions (e.g., actinic keratosis, BCC, and squamous cell carcinoma) in up to 5...
Brand Name : MW005
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 26, 2021
Details:
NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: NexoBrid
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2021
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hou...
Brand Name : NexoBrid
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 29, 2021
Details:
MediWound has entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group, an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns.
Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: NexoBrid
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Ghassan Aboud Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 14, 2020
Lead Product(s) : Bromelain
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Ghassan Aboud Group
Deal Size : Undisclosed
Deal Type : Partnership
Details : MediWound has entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group, an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns.
Brand Name : NexoBrid
Molecule Type : Large molecule
Upfront Cash : Undisclosed
December 14, 2020
Regulatory Info :
Registration Country : Sweden
Brand Name : NexoBrid
Dosage Form : POWDER AND GEL TO GEL
Dosage Strength : 2 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
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Regulatory Info :
Registration Country : Sweden
Brand Name : NexoBrid
Dosage Form : POWDER AND GEL TO GEL
Dosage Strength : 5 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Regulatory Info :
Registration Country : Sweden
Brand Name : NexoBrid
Dosage Form : POWDER AND GEL TO GEL
Dosage Strength : 2 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
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Regulatory Info :
Registration Country : Sweden
Brand Name : NexoBrid
Dosage Form : POWDER AND GEL TO GEL
Dosage Strength : 5 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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ABOUT THIS PAGE
A Bromelain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromelain, including repackagers and relabelers. The FDA regulates Bromelain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromelain API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Bromelain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromelain supplier is an individual or a company that provides Bromelain active pharmaceutical ingredient (API) or Bromelain finished formulations upon request. The Bromelain suppliers may include Bromelain API manufacturers, exporters, distributors and traders.
click here to find a list of Bromelain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromelain DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromelain active pharmaceutical ingredient (API) in detail. Different forms of Bromelain DMFs exist exist since differing nations have different regulations, such as Bromelain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromelain DMF submitted to regulatory agencies in the US is known as a USDMF. Bromelain USDMF includes data on Bromelain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromelain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromelain suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Bromelain Drug Master File in Japan (Bromelain JDMF) empowers Bromelain API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Bromelain JDMF during the approval evaluation for pharmaceutical products. At the time of Bromelain JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Bromelain suppliers with JDMF on PharmaCompass.
Bromelain Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Bromelain GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Bromelain GMP manufacturer or Bromelain GMP API supplier for your needs.
A Bromelain CoA (Certificate of Analysis) is a formal document that attests to Bromelain's compliance with Bromelain specifications and serves as a tool for batch-level quality control.
Bromelain CoA mostly includes findings from lab analyses of a specific batch. For each Bromelain CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Bromelain may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromelain EP), Bromelain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromelain USP).
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